Eisai, Inc.
Form 483 issued December 21, 2018 · Kakamigahara, Japan
- Inspection
- Dec 11 – Dec 21, 2018
- Observations
- 7
- Pages
- 4
- FEI number
- 3004967045
In short: On December 21, 2018, FDA issued a Form 483 with 7 observations to Eisai, Inc. in Kakamigahara, Gifu (FEI 3004967045) after an inspection that ran Dec 11 – Dec 21, 2018. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and quality system account for 5 of 7 observations.
What FDA observed
Preview: the opening words of each observation- 01
Time limits are not established when appropriate for the completion of each production phase to assure…
- 02
Written procedures for cleaning and maintenance fail to include instructions for removal or obliteration…
- 03
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the…
- 04
Routine inspection of equipment is not performed according to a written program designed…
This inspection in context
Questions about this 483
What did FDA find at Eisai, Inc.?
FDA listed 7 observations on this Form 483, mostly about facilities & equipment, quality system and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
When was Eisai, Inc. inspected by FDA?
The inspection ran Dec 11 – Dec 21, 2018, and the Form 483 is dated December 21, 2018.
How do I get the full Form 483 for Eisai, Inc.?
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